Olympus Corporation of the Americas 2023-08-30 Health serious FDA
Health · FDA · Recall #FDA-Z-2447-2023
The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC… Recall
Issued August 30, 2023 · Olympus Corporation of the Americas
In August 2023, Olympus Corporation of the Americas recalled the The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.
What you should do
- 1 Stop using The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- August 30, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2447-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.